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Experimental Research on Deep Carious Lesion Treatment of Molars (VITAPULP)

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ClinicalTrials.gov Identifier: NCT03626740
Recruitment Status : Recruiting
First Posted : August 13, 2018
Last Update Posted : August 13, 2018
Sponsor:
Information provided by (Responsible Party):
Andreea Didilescu, DDS, Carol Davila University of Medicine and Pharmacy

Brief Summary:

Maintaining dental pulp vitality is crucial for tooth preservation and functionality. Untreated dental caries may lead to pulp necrosis and infection, affecting children's growth and well-being. The first permanent teeth erupt around 6 years old. These are the first molars (FPM), which are frequently affected by caries, soon after their eruption.

In the present application, our main goal is to determine whether two treatment groups (MTA and TheraCal) are long-term effective in preserving pulp vitality among children' FPM affected by deep caries.


Condition or disease Intervention/treatment Phase
Dental Caries in Children Other: TheraCal Other: MTA Not Applicable

Detailed Description:

Among the most frequently used materials for pulp capping are calcium hydroxide, mineral trioxide aggregate (MTA), and, more recent, TheraCal. All of them are biocompatible and induce the formation of coronal hard tissue barriers (tertiary reparative dentin). Calcium hydroxide, considered for a long time the gold standard of direct pulp capping materials, has excellent antibacterial and remineralisant properties; however, it lacks adhesion, especially at moist dentin, and reparative dentin is less homogenous.

MTA proved to stimulate protective dentin bridge formation without inflammatory changes and least necrosis. It is also moisture tolerant, but it is more expensive, has poor handling characteristics and slow setting time.

TheraCal bonds to deep moist dentin, has strong physical properties, no solubility, high radioopacity and higher calcium releasing abilities than MTA or calcium hydroxide.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Experimental Research on Deep Carious Lesion Treatment of Permanent Molars in Children, Aiming to Preserve Dental Pulp Vitality
Actual Study Start Date : January 8, 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

Arm Intervention/treatment
Experimental: TheraCal
Indirect pulp capping with TheraCal
Other: TheraCal
Caries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with TheraCal

Active Comparator: Mineral trioxide aggregate (MTA)
Indirect pulp capping with MTA
Other: MTA
Caries removal without pulp exposure (stepwise excavation) followed by indirect pulp capping with MTA




Primary Outcome Measures :
  1. Clinical pulpal survival rate [ Time Frame: 20 months ]
    Pulpal survival is defined by positive response without lingering sensation to the cold test, absence of clinical signs and symptoms, and no apical radiolucency on the periapical radiograph.


Secondary Outcome Measures :
  1. Incidence of apical root maturation (apexogenesis) [ Time Frame: 20 months ]
    We will investigate the treatment effect on apexogenesis in children who had incomplete root formation at the beginning of the study and preserve their pulp vitality at the end of the study. The outcome will be compared radiographically with apical maturation in molar pairs (healthy contralateral molar, where applicable).



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • untreated deep uncomplicated carious lesions in first permanent molars (FPM)
  • absence of clinical diagnosis of pulp exposure
  • fistula
  • swelling of periodontal tissues
  • abnormal tooth mobility
  • history of spontaneous pain or sensitivity to percussion
  • healthy appearance of adjacent gingiva
  • normal tooth color
  • positive vitality to thermal and electric tests.

Exclusion Criteria:

  • FPM with previous treatment
  • FPM with developmental abnormalities (such as enamel hypoplasia, dentinogenesis imperfecta etc.)
  • children with mental disabilities or systemic diseases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03626740


Contacts
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Contact: Andreea C Didilescu, DDS, PhD +40722536798 andreea.didilescu@umfcd.ro

Locations
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Romania
Division of Pedodontics, Faculty of Dental Medicine Recruiting
Bucharest, Romania
Contact: Silvia Per, DDS         
Principal Investigator: Silvia Per, DDS         
Sponsors and Collaborators
Carol Davila University of Medicine and Pharmacy
Investigators
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Principal Investigator: Andreea C Didilescu, DDS, PhD Carol Davila University of Medicine and Pharmacy

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Responsible Party: Andreea Didilescu, DDS, Vice dean for Research, Professor, Carol Davila University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT03626740     History of Changes
Other Study ID Numbers: PN-III-P4-ID-PCE-2016-0506
First Posted: August 13, 2018    Key Record Dates
Last Update Posted: August 13, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andreea Didilescu, DDS, Carol Davila University of Medicine and Pharmacy:
dental pulp
deep carious lesions
treatment effect
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases